FDA busts e-cigarette sellers but stays silent on tough rules for device makers

eddie-300x169The Food and Drug Administration has cracked down on illegal sales of vaping devices to minors,  taking aim at the suddenly trendy, pricey, and small Juul e-cigarette. But this aggressive regulatory move itself added to criticism of the agency for its failure to clamp down on a key way kids get dosed with nicotine, a highly addictive substance the FDA hopes to slash from tobacco cigarettes.

April, the agency announced, not only has brought showers but also nationwide, month-long undercover raids and citations by enforcement agents for retailers accused of flouting FDA regulations that bar e-cigarette sales to Americans younger than 21.

The FDA also told Juul’s maker that it must produce a raft of documents and explain how and why its product exploded in popularity, dominating in market share and raising questions about how much nicotine users can get from the vaping device — typically as much as a pack of tobacco cigarettes.

The FDA leaped into action after anti-tobacco advocates sued the agency, arguing it improperly had, under new Commissioner Scott Gottlieb, let e-cigarette and other vaping device makers off the hook for several years from already announced plans for tighter regulation of their products.

Teens, technology, and seemingly Juul’s maker also played hard to ignore: Multiple news organizations reported the anger and frustration by schools, teachers, and administrators who complained that this kind of e-cigarette had become nearly uncontrollable in its use and popularity on campuses nationwide, and especially in upscale high schools where youngsters could afford the $50 for device starter kits.

Gottlieb issued a statement in which he criticized e-cigarettes:

The nicotine in these products can rewire an adolescent’s brain, leading to years of addiction. [The devices also] may offer a potentially lower risk alternative for individual adult smokers. But the viability of these products is severely undermined if those products entice youth to start using tobacco and nicotine.

Gottlieb, who served on the board of an e-cigarette maker before heading the FDA, did not address the agency’s decision to delay planned, tougher regulation of the devices, which he did note the FDA has gotten online auction retailer E-Bay to keep off its service.

In my practice, I see not only the big harms that patients suffer while seeking medical services but also the major damage that can be inflicted on them by smoking and nicotine addiction. Research has shown beyond a doubt that cigarettes are a leading cause of several different kinds of cancers, and a significant contributor to other heart and lung diseases. A growing number of studies also point to how e-cigarettes, and their fostering of addictive nicotine use, act as a gateway for young people to take up destructive cigarette smoking. Concern also has grown about vaping and harms that users may suffer due to their liquids and substances in them, as well as that occur when these get turned into user-inhaled “smoke.”

Gottlieb’s e-cigarette crackdown is a reasonable step, and shows him to be more responsive to the public and his responsibilities and duties, say, than disgraced Health and Human Services chief Tom Price, ousted Centers for Disease Control and Prevention head Brenda Fitzgerald, dismissed Veterans Administration Secretary David Shulkin, and, yes, now withdrawn VA nominee Ronny Jackson. Did I mention that Robert Redfield, a doctor and a former University of Maryland School of Medicine HIV-AIDS researcher, also is taking fire for the princely $375,000-a-year salary he’s supposed to get to run the CDC? (He since has asked that his pay, which was to be $100,000 or so more than his two predecessors, be cut, though it has not been disclosed what it finally will be.)

Still, there’s skepticism about Gottlieb and Big Tobacco, and whether he’s playing a “long con,” in which he advocates for regulatory changes that cannot be put in place until so far in the future that it’s like giving cigarette, cigar, and e-cigarette makers a pass. Let’s hope not. Let’s also hope that we’re not seeing the equivalent of a ploy as dated as that practiced by the oleaginous “Leave it to Beaver” TV character Eddie Haskell, with Gottlieb talking a respectful, good game but not meaning a bit of it.

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